Twynsta 80mg/5mg Boehringer Treatment of hypertension (14 blisters x 7 tablets)

Caution when using

Hepatic failure:

Telmisartan is excreted mainly through bile. It is expected that the clearance of patients with bile congestion or liver failure. In addition, like calcium antagonists, the semi -waste time of amlodipine is prolonged.

Patients with liver failure and recommendations for these patients have not been set. Therefore, Twynsta should be used carefully in these patients.

Hypertension caused by kidney artery

Has the potential to increase the risk of severe hypotension and renal function when the patient has narrowed kidney artery on both sides or the kidney stenosis to the only kidney is still the function treated with drugs that affect the renin-anidensin-krosterone system.

kidney failure and kidney transplant

Recommendations should monitor the concentration of potassium and serum creatinine when using Twynsta in patients with renal impairment. There is no experience in using Twynsta in new kidney transplant patients.

Reducing internal volume:

Symptomic low blood pressure, especially after the first dose, can occur in patients with a decrease in volume and/or sodium reduction, for example, due to excessive diuretic treatment, too strict salt, diarrhea or vomiting. Should treat such conditions before using Twynsta.

Double Renin-Anotensin-Aldosterone System:

There has been a report on renal function changes (including acute renal failure) due to the inhibition of the Renin-Anotensin-Reposterone system in sensitive patients, especially if used in conjunction with influential drugs on this system.

Twynsta can be used with other anti-hypertension drugs, but it is not recommended that the double-renin-analiotensin-aldosterone closing system (for example, a combination of an additional enamel inhibitor or Aliskiren directly inhibitors with an angiotensin I receptor antagonist I) and thus limit the specifically defined cases that need to be strictly monitored by kidney function.

Other conditions have the stimulation of the renin-anidensin-aldosterone system

In patients with vascular force and renal function depending largely on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or kidney disease, including kidney artery stenosis), the treatment with drugs affects the renin angiotensin-aldosterone system is associated with acute blood pressure drop, nitrogen nitrogen or rarely causing acute impairment.

Increase primary Aldosterone

In general, patients with primary aldosterone increases often do not respond to anti -hypertension drugs through inhibiting the Renin Angiotensin system. Therefore, it is not recommended the use of Telmisartan.

Aortic valve stenosis and mitral valve hypertrophy:

As well as for other vasodilators, special attention should be paid to patients with aortic valve stenosis or mitral valve, or hypertrophic cardiomyopathy.

Unstable angina, acute myocardial infarction:

There is no data on the use of twynsta in unstable angina patients and during or within a month of myocardial infarction.

heart failure:

In a long-term study, there is a placeborn with a placebo (praise-2) of amlodipine in patients with heart failure III and IV according to NYHA classification without the cause of ischemia, Amlodipine related to increased number of advertisements, although there is no significant difference in the proportion of patients with severe heart failure compared to placebo.

Hemorrhage:

During treatment with drugs that affect the Renin Angiotensin-aldosterone system may appear hyperkalemia, especially when patients with kidney failure and/or heart failure. The monitoring of serum potassium is recommended in patients at risk.

Based on the experience of use with drugs that affect the Renin-Anotensin, simultaneous use with potassium diuretics, potassium supplements, salt-containing salt or other drugs that can cause increased potassium concentration (for example, heparin) can increase serum potassium and thus be careful when used with Telmisartan.

Sorbitol

Do not take this drug in patients with rare genetic diseases with fructose intolerance.

diabetes

In patients with diabetes, there is an additional cardiovascular risk, for example a patient with diabetes with coronary artery disease (CAD), the risk of myocardial infarction leading to death and death from external cardiovascular disease.

can increase when treated with medications that reduce blood pressure such as ARB and ACE inhibitors. In patients with diabetes, coronary artery disease (CAD) may have no manifestations and therefore not diagnosed. Patients with diabetes should be evaluated and diagnosed appropriately, for example, experimental exertion, to detect and treat an appropriate coronary artery disease before treatment with Twynsta.

Other caution:

Twynsta is effective when used in black skin patients (usually a group of patients with low renin content). Like other anti -hypertension drugs, excessive blood pressure lowering in patients with ischemia or cardiovascular disease due to ischemia. Can lead to myocardial infarction or stroke.

The ability to drive and operate machinery

There has been no research on the effect of the drug on the ability to drive and operate machinery.

However, when driving or operating machinery, you should pay attention to unwanted effects that may occur such as fainting, sleeping, dizziness, or dizziness during treatment.

Therefore, it is advisable to recommend patients to be cautious when driving and operating machinery. If patients experience these unwanted effects, they should avoid risks such as driving or operating machinery.

Pregnancy

should not start treatment with Angiotensin II receptor antagonists during pregnancy. Patients planning to get pregnant should switch to alternative anti -hypertension therapies that have safe data proved to be used during pregnancy unless the continued use of Angiotensin II receptor is considered essential.

When diagnosed with pregnancy, immediately stop treatment with angiotensin II receptor antagonists, and if appropriate, should start with an alternative therapy.

The period of breastfeeding

It is not known whether Telmisartan and/or Amlodipine are excreted in human milk. Animal studies show that Telmisartan is excreted in milk. Due to the possibility of adultery effects in breastfeeding, it is important to decide whether to stop breastfeeding or stopping treatment, depending on the importance of this drug for the mother.

Drug interaction

does not observe the interaction between the two components of the form of fixed combination of data in clinical trials.

The common interactions of the combined form have not yet conducted studies on drug interactions of Twynsta and other drugs.

Note when using simultaneously

Other anti -hypertension drugs: The effect of reducing blood pressure of Twynsta may be increased due to simultaneous use with other anti -hypertension drugs.

The drugs are capable of lowering blood pressure: Based on pharmacological properties, it is thought that some of the following drugs are likely to increase the lowering effectiveness of all anti -hypertension drugs including Twynsta, for example, Baclofen, amifostine. In addition, vertical low blood pressure may be worse due to alcohol, barbiturates, addictive drugs, or antidepressants.

corticosteroid (systemic line): reduces the effectiveness of anti -hypertension.

Telmisartan interactions

Telmisartan may increase the lower pressure of other anti -hypertension drugs. Uncultivated other significant interactions are clinically.

Simultaneous use of Telmisartan and Digoxin, Warfarin, Hydrochlorothiazide, Glibenclamide, Ibuprofen, Paracetamol, Simvastatin and Amlodipine does not lead to any significant interaction clinically. For Digoxin, it has observed the phenomenon of 20% increase in the median concentration of digoxin in plasma (39% in a single case), should consider monitoring digoxin levels in plasma.

In a simultaneous study of Telmisartan and Ramipril, resulting in an increase of 2.5 times AUC and CMAX of Ramiprilvà Ramiprilat. The clinical significance of this finding is not known. There has been a report on the inverse of serum and toxic lithium concentration while using simultaneously lithium with enzyme inhibitors.

Some cases have also been reported to Angiotensin II antagonists including Telmisartan. Therefore, serum lithium concentration should be monitored when used simultaneously.

Treatment with NSAID (specifically ASA at anti-inflammatory doses, non-selective COX-2 and NSAID inhibitors) are associated with the ability to cause renal impairment of dehydrated patients.

The active ingredients acting on the Renin Angiotensin system like Telmisartan may be effective in union.

Patients using NSAID and Telmisartan should be fully rehydrated and should be monitored with kidney function when starting combined treatment. There has been a report on the effectiveness of anti -hypertension drugs such as Telmisartan due to inhibition of prostaglandin causing vasodilation during the combination of NSAID treatment.

Interactions related to amlodipine

Caution Causes when treating simultaneously

grapefruit and grapefruit juice

It is recommended that not using twynsta along with grapefruit or grapefruit juice can increase in some patients leading to increased blood pressure reduction effect.

CYP3A4 inhibitors in an elderly patient study showed that the metabolic inhibitor of amlodipine, can be through CYP3A4 (plasma concentrations increased by about 50% and the effectiveness of amlodipine is increased) without except the possibility of stronger CYP3A4 inhibitors (for example, ketoconazole, iTraconazole, ritonavir) Amlodipine's similarities are more than diltiazem.

CYP3A4 enzyme induction drugs (anti -convulsions (e.g. carbamazepine, phenobarbital, phenytoin, phosphenytoin, primidonel, rifampicin, hypericum perforatum)). Use simultaneously can reduce amlodipine levels in plasma.

Note when using simultaneously

simvastatin: simultaneously use amlodipine and simvastatin 80 mg resulting in an increase in simvastatin levels up to 77% compared to Simvastatin used single therapy. Therefore, the simvastatin dose should be limited to 20 mg daily on patients using amlodipine.

Amlodipin immunosuppressant drugs may cause increased body absorption of cyclosporin or tacrolimus when used simultaneously. Recommendations regularly monitor the bottom concentration of cyclosporin and tacrolimus and adjust the dose as needed.

Other notes

In single therapy, amlodipine is used safely with thiazide diuretics, beta blockers, enzyme inhibitors (ACE), long -lasting nitrate, nitroglycerin -formed nitroglycerin, anti -inflammatory steroids, antibiotics and oral hypoglycemic drugs. When using a combination of Amlodipine and Sildenafil, the hypotension effect of each drug is independent.

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